# ADAURA

Source: https://onco.cc/trials/adaura/  
OnCo record `adaura` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Showed a targeted pill after lung cancer surgery halves the risk of death, the first such result for a targeted therapy.

## Summary

ADAURA, trial NCT02511106 sponsored by AstraZeneca and reported in 2020 with survival results in 2023, showed that three years of osimertinib after resection of stage IB to IIIA EGFR-mutant non-small-cell lung cancer halves the risk of death, the first such result for a targeted therapy. It randomised 682 patients to osimertinib or placebo, met its primary disease-free survival endpoint in stage II to IIIA disease with a very large effect, and showed an overall survival benefit at five years. OnCo links it to non-small-cell lung cancer, EGFR as a target, osimertinib, Roy S. Herbst, Yi-Long Wu, ALINA, the Chinese Thoracic Oncology Group, Guangdong Provincial People's Hospital, the FLAURA and ADAURA papers and terms on data maturity and EGFR mutation subtypes. Whether three years is the right duration is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-04
- Also known as: Adjuvant osimertinib after complete resection of EGFR-mutant lung cancer; ADAURA trial
- Registry id: NCT02511106
- Phase: 3
- Setting: Adjuvant osimertinib 3 years after resection of stage IB-IIIA EGFR-mutant NSCLC
- Sponsor: AstraZeneca
- Enrolled: 682
- Result: OS HR 0.49.
- Outcomes: Disease-free survival, stage II to IIIA: Osimertinib vs Placebo 19.6 months, HR 0.17; Overall survival at 5 years, stage II to IIIA: Osimertinib 85% vs Placebo 73%, HR 0.49; Overall survival at 5 years, stage IB to IIIA: Osimertinib 88% vs Placebo 78%, HR 0.49; 8-year overall survival, stage II to IIIA: Osimertinib 74% vs Placebo 58%, HR 0.53; 8-year overall survival, stage IB to IIIA: Osimertinib 79% vs Placebo 64%, HR 0.52
- Replication: Single pivotal adjuvant trial with an OS benefit; consistent with the adjuvant ALK result (ALINA) and with earlier-generation adjuvant EGFR TKI trials that improved DFS.

## Notes

- Long-term follow-up. The exploratory landmark analysis published in the Journal of Thoracic Oncology in 2026 (data cutoff 4 May 2026) reports the longest overall survival from any global phase 3 adjuvant trial in EGFR-mutated stage IB to IIIA non-small-cell lung cancer. In the stage II to IIIA population the overall survival hazard ratio was 0.53 (95 percent confidence interval 0.38 to 0.75) and eight-year overall survival 74 percent with osimertinib against 58 percent with placebo, at a median follow-up of 92.0 against 68.5 months. In the whole stage IB to IIIA population the hazard ratio was 0.52 (0.39 to 0.71) and eight-year overall survival 79 against 64 percent. The benefit was larger for exon 19 deletions (0.45, 0.29 to 0.68) than for L858R (0.72, 0.46 to 1.11). Updated survival data were collected from 431 of the 558 patients alive at the planned final analysis; the remaining 127 stayed censored at the earlier cutoff.
- In England NICE TA1043 (26 February 2025) funds adjuvant osimertinib only if it is stopped at 3 years, or earlier on recurrence or unacceptable toxicity; the trial gave it for 3 years.

## Sources

- ClinicalTrials.gov NCT02511106: https://clinicaltrials.gov/study/NCT02511106
- ADAURA 8-year overall survival landmark update (Journal of Thoracic Oncology 2026): https://doi.org/10.1016/j.jtho.2026.104179
- NICE TA1043: osimertinib for adjuvant treatment of EGFR mutation-positive non-small-cell lung cancer after complete tumour resection: https://www.nice.org.uk/guidance/ta1043

## Connected records

- cancers: [EGFR-mutated non-small-cell lung cancer](https://onco.cc/cancers/egfr-mutant-nsclc/), [Lung cancer (all types)](https://onco.cc/cancers/lung-cancer/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Resectable stage I to III non-small-cell lung cancer](https://onco.cc/cancers/resectable-nsclc/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [EGFR](https://onco.cc/targets/egfr/)
- drugs: [Osimertinib](https://onco.cc/drugs/osimertinib/)
- companies: [Chinese Thoracic Oncology Group](https://onco.cc/companies/ctong/)
- trials: [ALINA](https://onco.cc/trials/alina/), [IALT (International Adjuvant Lung Cancer Trial)](https://onco.cc/trials/ialt/), [KEYNOTE-091 (PEARLS)](https://onco.cc/trials/keynote-091/), [LACE (Lung Adjuvant Cisplatin Evaluation) pooled analysis](https://onco.cc/trials/lace-pooled-analysis/), [Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [](https://onco.cc/trials/nct02486718/)
- people: [Roy S. Herbst](https://onco.cc/people/roy-herbst/), [Yi-Long Wu](https://onco.cc/people/wu-yi-long/)
- key papers: [ADAURA: exploratory eight-year overall survival update for adjuvant osimertinib in resected EGFR-mutated stage IB to IIIA lung cancer](https://onco.cc/key-papers/paper-adaura-8-year-os-jto-2026/), [ADAURA: three years of osimertinib after surgery for EGFR-mutated lung cancer](https://onco.cc/key-papers/paper-adaura-nejm-2020/), [FLAURA: osimertinib as first treatment for EGFR-mutated lung cancer](https://onco.cc/key-papers/paper-flaura-nejm-2018/)
- terms: [Absolute versus relative benefit (number needed to treat)](https://onco.cc/terms/absolute-benefit/), [Data maturity (immature vs mature survival data)](https://onco.cc/terms/data-maturity/), [Data monitoring committee (DSMB, IDMC)](https://onco.cc/terms/data-monitoring-committee/), [EGFR mutation subtypes (exon 19 deletion, L858R, exon 20 insertion, T790M)](https://onco.cc/terms/egfr-mutation-subtypes/), [Event-free / disease-free survival (EFS, DFS, iDFS, RFS)](https://onco.cc/terms/efs/), [Group sequential design, stopping rules and alpha spending](https://onco.cc/terms/group-sequential-design/), [Hazard ratio (HR)](https://onco.cc/terms/hazard-ratio/), [Interim analysis, readout and data cut-off](https://onco.cc/terms/interim-analysis/), [Kaplan-Meier curve, censoring and proportional hazards](https://onco.cc/terms/kaplan-meier-curve/), [Lobectomy](https://onco.cc/terms/lobectomy/), [Overall survival (OS)](https://onco.cc/terms/os/), [Phase 1, 2 and 3 trials](https://onco.cc/terms/trial-phases/), [Pivotal (registrational) trial](https://onco.cc/terms/pivotal-trial/), [Randomised trial](https://onco.cc/terms/randomised-trial/), [Statistical power, sample size and re-estimation](https://onco.cc/terms/sample-size-re-estimation/), [Surrogate endpoint validation: which stand-ins have earned trust](https://onco.cc/terms/surrogate-validation/), [Trial lifecycle: from protocol to label](https://onco.cc/terms/trial-lifecycle/)
- ideas: [Add the second drug on day one when the escape route is predictable](https://onco.cc/ideas/idea-bio1-upfront-bypass-combination/), [Autonomous closed-loop adaptive therapy driven by blood tests and evolutionary models](https://onco.cc/ideas/idea-moon-closed-loop-adaptive-therapy/), [Prevention trials aimed only at brain metastasis](https://onco.cc/ideas/idea-bio2-brain-met-prevention-trials/)
- institutions: [Guangdong Provincial People's Hospital](https://onco.cc/institutions/guangdong-provincial-peoples-hospital/)
- roadmaps: [Targeted therapy roadmap: imatinib → designed for resistance → the undruggable drivers fall](https://onco.cc/roadmaps/targeted-therapy-roadmap/)

---
JSON: https://onco.cc/api/v1/entities/adaura.json